FDA Panel Calls Current Duodenoscopes Unsafe

Asked if the devices were reasonably safe and effective, every member answered "no"

SILVER SPRING, Md. -- Carla Warner, who lives in North Carolina, lost her husband to a carbapenem-resistant Enterobacteriaceae (CRE) infection in 2013. When she learned his death was caused by a contaminated duodenoscope and could have been prevented, she was crushed but also angry.

During the public portion of an FDA panel on Thursday, she challenged the FDA: "What does being a watchdog mean, if you have no real authority over those you are watching?"

At the end of a 2-day meeting on Friday, members of the agency's advisory committee on gastroenterology devices unanimously agreed that the current generation of devices do not offer "reasonable assurance of safety and efficacy," and called for development of new protocols to ensure that reprocessing them after use leaves them reliably sterile.

In the last few years, over a dozen patients have died from CRE infections or "superbugs" at the UCLA Medical Center in Los Angeles, and the Virginia Mason Medical Center in Seattle after procedures using duodenoscopes. At least four other hospitals have documented outbreaks. Investigations revealed the deaths were caused by contaminated scopes.

In March, the FDA told doctors that they should not discontinue using duodenoscopes -- even the Olympus model involved in the death of Warner's husband, which had not received FDA's clearance -- because there aren't enough of the devices available to shelve one brand without compromising treatment of patients who need therapies requiring them. The agency has issued multiple letters, convened meetings and summits, and published guidance documents about the devices. FDA representatives said they are in "constant dialogue" with the manufacturers of duodenoscopes who are interested in the committee's input.

At this week's 2-day meeting, the FDA sought input from members of its Gastroenterology and Urology Devices advisory committee, who explored ways to develop more rigorous cleaning and disinfection processes for duodenoscopes to prevent further outbreaks and deaths,

The devices in question are endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes, used in diagnosing and sometimes treating problems of the bile and pancreatic ducts. "Treatment may consist of dilation of the bile duct, insertion of a stent, removal of gallstones, or biopsy of lesions around the ampulla (opening of the bile ducts into the duodenum)," noted FDA technical documents.

A buildup of bile can lead to sepsis and even death. Alternative treatments such as laparoscopic or open surgical procedures also carry significant risks.

In introductory remarks, Stephen Ostroff, MD, acting commissioner of the FDA, explained the unique features of duodenoscopes, include a "working channel" that allows for injection of imaging contrast agents and allow "side visualization" through a camera.

"Their intricacy is in part what allows them to perform a very complex medical procedure," Ostroff, said but it's their own complexity -- constructed with tiny screws and doors and levers -- that also make the instruments more difficult to clean, disinfect, or sterilize.

"We need to take steps to assure [patients] – and health providers that perform the procedures – that this procedure can be done as safely and effectively as possible," Ostroff said.

The FDA has long been tracking the issue of infections with these devices and, up until 2013, they believed the primary cause of infections was human error. Later analysis found that transmission still occurred even with meticulous adherence to protocols, explained Susanne Schwartz, MD, MBA, director of Emergency Preparedness Operation and Medical Countermeasures at the FDA's Center for Devices and Radiological Health.

Michelle Alfa, PhD, a microbiologist at the University of Manitoba, emphasized the importance of manual cleaning to remove organic materials and adequately drying duodenoscopes. Blood, fecal matter, or any other residue will provide food for bacteria. Residue will also undermine sterilization.

Any moisture can lead to bacterial growth and hard-to-remove biofilms. "You need to be sure that those scopes are stored bone dry," she said.

After two days discussing the design of the devices, their hard-to-reach nooks and crannies, the skill level of the employees who clean them -- including their low-pay and high turnover -- and the relative effectiveness of sterilization methods versus disinfection, the FDA asked the committee for feedback.

When asked whether duodenoscopes offered "reasonable assurance of safety and effectiveness," every member answered "no." When the FDA reframed the question asking whether duodenoscopes should still be used, all of the members agreed that they were needed for treatment, though not necessarily diagnosis of certain conditions. The alternative intervention, an invasive surgery, carries such high risks that it is "almost never done," said Chairman Mark Talamini, MD, of Stony Brook School of Medicine in New York.

To reduce the risk of infection with duodenoscopes, the committee recommended:

Appropriate patient selection

Standardized cleaning process

Assessment following cleaning

Proper disinfection or sterilization

Attention to drying and storage

Surveillance to asses germ levels following disinfection or sterilization

Karen Woods, MD, a Houston gastroenterologist in private practice, said that performing diagnostic ERCPs was inappropriate, when safer methods are available. She and other committee members stressed that physicians should explain the risk of infection, and let patients who are at higher risk -- those whose immune systems are already compromised -- know this as well. Providers should also explain the steps that have been taken to mitigate patient risks and the high risks of other procedures.

The committee acknowledged that the cleaning process needed to be well-defined. They stressed that hospitals should not rely on 100-page manuals, but instead use videos and other instructional methods, because some workers may have literacy challenges.

Panel member Mary Olivera, MS, a clinical consultant from Newburgh, N.Y., suggested that certification would boost worker morale, though other committee members felt that competency assessments would suffice.

Roughly two-thirds of members said that sterilization was the best practice for cleaning duodenoscopes. Sterilization is expensive and requires more time than high-level disinfection. In addition, chemicals, such as ethylene oxide, involved in some of the most commonly offered processes can cause illness, including cancer, if there isn't proper air circulation.

Gary Roselle, MD, director of the Department of Veterans Affairs Central Office and professor at the University of Cincinnati said, "The hazard of [ethylene oxide] is not small."

Even knowing the proper precautions, "people still do everything wrong," he continued. Yet, the shift to sterilization is "inevitable."

The panel unanimously agreed that the interim CDC guidelines were not sufficient to be used as best practice but that best practices should be established.

While manufacturers of automated endoscope re-processors, the devices used to sterilize duodenoscopes, were present, duodenoscope manufacturers "declined to formally participate" in the meeting, according to the FDA.

The agency has no authority to require device manufacturers to change designs. All it can do is withdraw clearances of devices found to be too unsafe to justify continued use, and to require changes to device labeling. But it can't require hospitals to follow label directions.

"As of right now, we recommend that everybody follow the manufacturing label for cleaning and for high-level disinfection because that's what the companies have," said Benjamin Fisher, PhD, director of the Division of Reproductive Gastro-Renal and Urological Devices for the FDA, who spoke in the presence of a public relations representative.

"We have gone back to all three manufacturers, and asked them for data [related to contamination levels] and for their cleaning protocol." If these are not "stringent enough," the FDA will take steps to improve them, he said.

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